evaluation of safety, tolerability, pharmacokinetics, and antiretroviral activity of ulonivirine (mk-8507) in human immunodeficiency virus (hiv-1)-infected participants (mk-8507-003)

Conditions: HIV-1 Infection

Summary: the study will evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of a single dose of ulonivirine in antiretroviral therapy (art)-naive, hiv-1 infected participants. the hypothesis tested in the study is that at a safe and well-tolerated dose, ulonivirine has superior antiretroviral activity to a historical placebo control, as measured by change from baseline in plasma hiv-1 ribonucleic acid (rna) at 168 hours postdose.


Eligibility criteria:
inclusion criteria: * male, or non-pregnant and non-breastfeeding female, or postmenopausal or surgically sterile female (confirmed with medical records, examination, or laboratory test). male participants with female partner of childbearing potential agrees to use a medically acceptable method of contraception during the study and 90 days after receiving study drug. * body mass index \<=35 kg/m\^2 * other than hiv infection, baseline health judged to be stable at screening and/or prior to administration of study drug * no clinically-significant electrocardiogram abnormality * documented to be hiv-1 positive as determined by a positive enzyme-linked immunosorbent assay (elisa) or quantitative polymerase chain reaction (pcr) result with confirmation * has a screening plasma cluster of differentiation (cd4) t-cell count of \>200 /mm\^3 * has a plasma hiv-1 rna \>= 10,000 copies/ml within 30 days before administration of study drug * art-naive, defined as never having received any art agent, or have received \<=30 consecutive days of an investigational art agent, excluding non-nucleoside reverse transcriptase inhibitors (nnrtis), or have received \<=60 consecutive days of combination art, excluding nnrtis * has not received an investigational agent or licensed art within 30 days of study drug administration * diagnosed with hiv-1 infection \>=3 months before screening * willing to receive no other art for the duration of the study * has no evidence of mutations conferring resistance to nnrtis at screening exclusion criteria: * mentally or legally institutionalized or incapacitated, has significant emotional problems, or has a history of clinically significant psychiatric disorder * history of clinically significant and not stably controlled abnormalities or diseases * history of cancer, with the exceptions of 1) adequately-treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, 2) other malignancies which have been successfully treated \>=10 years before screening, or 3) participants who are highly unlikely to sustain a recurrence for the duration of the study * history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to drugs or food * positive for hepatitis b surface antigen * history of chronic hepatitis c virus (hcv) unless there has been a documented cure or a negative hcv viral load * had major surgery, or donated or lost \>=1 unit (\~500 ml) of blood within 4 weeks before screening * participated in another investigational trial within 4 weeks before administration of study drug * unable to refrain from or anticipates the use of any medication beginning 4 weeks before administration of study drug and throughout the trial. certain medications are permitted. * consumes \>3 glasses of alcoholic beverages per day (1 glass is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of distilled spirits). participants who consume 4 glasses of alcoholic beverages per day may be enrolled at the discretion of the investigator. * consumes \>10 cigarettes per day and is unwilling to restrict smoking to \<=10 cigarettes per day * regular user of any illicit drugs or has a history of drug abuse (including alcohol) within 2 years * has an immediate family member who is investigational site or sponsor staff directly involved with the trial